Composite Dressings For Improved Granulation And Reduced Maceration With Negative-Pressure Treatment

ABSTRACT

Dressings for treating a tissue site with negative pressure are disclosed, which may include a dressing having at least three layers assembled in a stacked relationship. In one example embodiment, a first film may comprise a non-porous material and a plurality of fluid restrictions. A first manifold layer may be adjacent to the first film and may comprise a second film of a transparent material having blisters and a manifold area. The first manifold layer may further comprise apertures configured to allow fluid transfer through the second film. A second manifold layer may be adjacent to the first manifold layer and may comprise foam having a contact area that is less than the manifold area of the first manifold layer.

RELATED APPLICATION

This application claims the benefit, under 35 U.S.C. § 119(e), of thefiling of U.S. Provisional Patent Application Ser. No. 62/633,438,entitled “COMPOSITE DRESSINGS FOR IMPROVED GRANULATION AND REDUCEDMACERATION WITH NEGATIVE-PRESSURE TREATMENT,” filed Feb. 21, 2018; U.S.Provisional Patent Application Ser. No. 62/623,325, entitled “METHODSFOR MANUFACTURING AND ASSEMBLING DUAL MATERIAL TISSUE INTERFACE FORNEGATIVE-PRESSURE THERAPY,” filed Jan. 29, 2018; U.S. Provisional PatentApplication Ser. No. 62/625,704, entitled “CUSTOMIZABLE COMPOSITEDRESSINGS FOR IMPROVED GRANULATION AND REDUCED MACERATION WITHNEGATIVE-PRESSURE TREATMENT,” filed Feb. 2, 2018; U.S. ProvisionalPatent Application Ser. No. 62/616,244, entitled “COMPOSITE DRESSINGSFOR IMPROVED GRANULATION AND REDUCED MACERATION WITH NEGATIVE-PRESSURETREATMENT,” filed Jan. 11, 2018; U.S. Provisional Patent ApplicationSer. No. 62/615,821, entitled “METHODS FOR MANUFACTURING AND ASSEMBLINGDUAL MATERIAL TISSUE INTERFACE FOR NEGATIVE-PRESSURE THERAPY,” filedJan. 10, 2018; U.S. Provisional Patent Application Ser. No. 62/613,494,entitled “PEEL AND PLACE DRESSING FOR THICK EXUDATE AND INSTILLATION,”filed Jan. 4, 2018; U.S. Provisional Patent Application Ser. No.62/592,950, entitled “MULTI-LAYER WOUND FILLER FOR EXTENDED WEAR TIME,”filed Nov. 30, 2017; U.S. Provisional Patent Application Ser. No.62/576,498, entitled “SYSTEMS, APPARATUSES, AND METHODS FORNEGATIVE-PRESSURE TREATMENT WITH REDUCED TISSUE IN-GROWTH,” filed Oct.24, 2017; U.S. Provisional Patent Application Ser. No. 62/565,754,entitled “COMPOSITE DRESSINGS FOR IMPROVED GRANULATION AND REDUCEDMACERATION WITH NEGATIVE-PRESSURE TREATMENT,” filed Sep. 29, 2017; U.S.Provisional Patent Application Ser. No. 62/516,540, entitled “TISSUECONTACT INTERFACE,” filed Jun. 7, 2017; U.S. Provisional PatentApplication Ser. No. 62/516,550, entitled “COMPOSITE DRESSINGS FORIMPROVED GRANULATION AND REDUCED MACERATION WITH NEGATIVE-PRESSURETREATMENT” filed Jun. 7, 2017; and U.S. Provisional Patent ApplicationSer. No. 62/516,566, entitled “COMPOSITE DRESSINGS FOR IMPROVEDGRANULATION AND REDUCED MACERATION WITH NEGATIVE-PRESSURE TREATMENT”filed Jun. 7, 2017, each of which is incorporated herein by referencefor all purposes.

TECHNICAL FIELD

The invention set forth in the appended claims relates generally totissue treatment systems and more particularly, but without limitation,to dressings for tissue treatment with negative pressure and methods ofusing the dressings for tissue treatment with negative pressure.

BACKGROUND

Clinical studies and practice have shown that reducing pressure inproximity to a tissue site can augment and accelerate growth of newtissue at the tissue site. The applications of this phenomenon arenumerous, but it has proven particularly advantageous for treatingwounds. Regardless of the etiology of a wound, whether trauma, surgery,or another cause, proper care of the wound is important to the outcome.Treatment of wounds or other tissue with reduced pressure may becommonly referred to as “negative-pressure therapy,” but is also knownby other names, including “negative-pressure wound therapy,”“reduced-pressure therapy,” “vacuum therapy,” “vacuum-assisted closure,”and “topical negative-pressure,” for example. Negative-pressure therapymay provide a number of benefits, including migration of epithelial andsubcutaneous tissues, improved blood flow, and micro-deformation oftissue at a wound site. Together, these benefits can increasedevelopment of granulation tissue and reduce healing times.

There is also widespread acceptance that cleansing a tissue site can behighly beneficial for new tissue growth. For example, a wound can bewashed out with a stream of liquid solution, or a cavity can be washedout using a liquid solution for therapeutic purposes. These practicesare commonly referred to as “irrigation” and “lavage” respectively.“Instillation” is another practice that generally refers to a process ofslowly introducing fluid to a tissue site and leaving the fluid for aprescribed period of time before removing the fluid. For example,instillation of topical treatment solutions over a wound bed can becombined with negative-pressure therapy to further promote wound healingby loosening soluble contaminants in a wound bed and removing infectiousmaterial. As a result, soluble bacterial burden can be decreased,contaminants removed, and the wound cleansed.

While the clinical benefits of negative-pressure therapy and/orinstillation therapy are widely known, improvements to therapy systems,components, and processes may benefit healthcare providers and patients.

BRIEF SUMMARY

New and useful systems, apparatuses, and methods for treating tissue ina negative-pressure therapy environment are set forth in the appendedclaims. Illustrative embodiments are also provided to enable a personskilled in the art to make and use the claimed subject matter.

For example, in some embodiments, a dressing for treating a tissue sitewith negative pressure may comprise a first film having a non-porousmaterial, a first manifold layer adjacent to the first film and having asecond film of transparent material, and a second manifold layeradjacent to the first manifold layer. The first film may further includea plurality of fluid restrictions. The second film of transparentmaterial of the first manifold layer may include blisters and a manifoldarea, as well as apertures configured to allow fluid transfer throughthe second film. The second manifold layer may include a foam having acontact area that is less than the manifold area.

In additional embodiments, a dressing for treating a tissue site withnegative pressure may comprise a film layer of non-porous material, aplurality of fluid restrictions through the film layer, a first manifoldlayer adjacent to the film layer, and a second manifold layer adjacentto the first manifold layer. The first manifold layer may include atransparent material and apertures configured to allow fluid transferthrough the first manifold layer. The second manifold layer may includea foam. The transparent material of the first manifold layer may beexposed around the foam.

In further embodiments, a dressing for treating a tissue site withnegative pressure may comprise a fluid control layer, a first manifoldlayer adjacent to the fluid control layer, and a second manifold layeradjacent to the first manifold layer. The first manifold layer may beconfigured to allow visibility of at least part of the tissue sitethrough the first manifold layer. The first manifold may be visiblearound the second manifold layer.

In yet additional embodiments, a dressing for treating a tissue sitewith negative pressure may comprise a lower layer comprising a firstfilm of at least partially transparent, liquid-impermeable material, anupper layer positioned above the lower layer, and an intermediate layerbetween the lower layer and the upper layer. The first film may furtherinclude a plurality of fluid restrictions to allow the passage of fluidfrom a wound site through the lower layer. The second film may include asecond transparent material and a fluid port for mating with a source ofnegative pressure. The intermediate layer may comprise foam, wherein thearea of the foam is less than the area of the lower layer to allowvisualization of a wound site underneath the upper and lower layers. Insome embodiments, the area of the foam may be less than 50% of the areaof the lower layer. In additional embodiments, the dressing may furtherinclude a third film coupled to the lower layer opposite the upperlayer. The third film may include a hydrophobic material having aplurality of apertures. In some embodiments, the hydrophobic materialmay be a silicone material.

In still additional embodiments, a dressing for treating a tissue sitewith negative pressure may comprise a first film comprising a non-porousmaterial, a second film adjacent to the first film, and a manifold layeradjacent to the second film. The second film may include a transparentmaterial and apertures configured to allow fluid transfer through thetransparent material. The manifold layer may include foam having acontact area that is less than the area of the second film.

In yet additional embodiments, a dressing for treating a tissue sitewith negative pressure may comprise a first film comprising a non-porousmaterial and a plurality of fluid restrictions, a second film adjacentto the first film, and a manifold layer adjacent to the second film. Thesecond film may include a transparent material having blisters. Thesecond film may also include apertures configured to allow fluidtransfer through the transparent material. The manifold layer mayinclude foam having a contact area that is less than the area of thesecond film.

In still additional embodiments, a dressing for treating a tissue sitewith negative pressure may comprise a first layer comprising a firstnon-porous material, a second layer adjacent to the first layer, and athird layer adjacent to the second layer. The second layer may include atransparent material having apertures configured to allow fluid transferthrough the second layer. The third layer may include a foam having acontact area that is less than an area of the transparent material ofthe second layer.

In yet further embodiments, a method for treating a tissue site maycomprise positioning a dressing on the tissue site, inspecting theposition of the dressing against areas of the tissue site, and adjustingthe position of the dressing. The dressing may comprise a first filmcomprising a non-porous material and having a plurality of fluidrestrictions, a first manifold layer adjacent to the first film, and asecond manifold layer adjacent to the first manifold layer. The firstmanifold layer may include a second film of a transparent materialhaving a manifold area comprising blisters and apertures. The secondmanifold layer may include a foam having a contact area that is lessthan the manifold area. The step of inspecting the position of thedressing against areas of the tissue site may include visualizing theareas of the tissue site through portions of the first film and firstmanifold layer. Adjusting the position of the dressing may be performedso that the manifold area of the dressing substantially corresponds toareas of the tissue site within borders of the tissue site.

Objectives, advantages, and a preferred mode of making and using theclaimed subject matter may be understood best by reference to theaccompanying drawings in conjunction with the following detaileddescription of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a functional block diagram of an example embodiment of atherapy system that can provide tissue treatment in accordance with thisspecification;

FIG. 2 is an assembly view of an example of a dressing illustratingadditional details that may be associated with some example embodimentsof the therapy system of FIG. 1;

FIG. 3 is a schematic view of an example configuration of fluidrestrictions in a layer that may be associated with some embodiments ofthe dressing of FIG. 2;

FIG. 4 is a schematic view of an example configuration of apertures inanother layer, illustrating additional details that may be associatedwith some embodiments of the dressing of FIG. 2;

FIG. 5 is a schematic view of the example layer of FIG. 4 overlaid onthe example layer of FIG. 3;

FIG. 6 is a perspective view of an example configuration of blisters inanother layer that may be associated with some embodiments of thedressing of FIG. 2;

FIG. 7 is a section view illustrating additional details that may beassociated with some embodiments of the layer of FIG. 6;

FIG. 8 is a schematic view of another example of a dressing illustratingadditional details that may be associated with some example embodimentsof the therapy system of FIG. 1;

FIG. 9 is a schematic view of another example of a dressing illustratingadditional details that may be associated with some example embodimentsof the therapy system of FIG. 1; and

FIG. 10 is an assembly view of another example of a dressingillustrating additional details that may be associated with some exampleembodiments of the therapy system of FIG. 1.

DESCRIPTION OF EXAMPLE EMBODIMENTS

The following description of example embodiments provides informationthat enables a person skilled in the art to make and use the subjectmatter set forth in the appended claims, but may omit certain detailsalready well-known in the art. The following detailed description is,therefore, to be taken as illustrative and not limiting.

The example embodiments may also be described herein with reference tospatial relationships between various elements or to the spatialorientation of various elements depicted in the attached drawings. Ingeneral, such relationships or orientation assume a frame of referenceconsistent with or relative to a patient in a position to receivetreatment. However, as should be recognized by those skilled in the art,this frame of reference is merely a descriptive expedient rather than astrict prescription.

FIG. 1 is a simplified functional block diagram of an example embodimentof a therapy system 100 that can provide negative-pressure therapy withinstillation of topical treatment solutions in accordance with thisspecification.

The term “tissue site” in this context broadly refers to a wound,defect, or other treatment target located on or within tissue, includingbut not limited to, a surface wound, bone tissue, adipose tissue, muscletissue, neural tissue, dermal tissue, vascular tissue, connectivetissue, cartilage, tendons, or ligaments. The term “tissue site” mayalso refer to areas of any tissue that are not necessarily wounded ordefective, but are instead areas in which it may be desirable to add orpromote the growth of additional tissue. For example, negative pressuremay be applied to a tissue site to grow additional tissue that may beharvested and transplanted. A surface wound, as used herein, is a woundon the surface of a body that is exposed to the outer surface of thebody, such as injury or damage to the epidermis, dermis, and/orsubcutaneous layers. Surface wounds may include ulcers or closedincisions, for example. A surface wound, as used herein, does notinclude wounds within an intra-abdominal cavity. A wound may includechronic, acute, traumatic, subacute, and dehisced wounds,partial-thickness burns, ulcers (such as diabetic, pressure, or venousinsufficiency ulcers), flaps, and grafts, for example.

The therapy system 100 may include negative-pressure supply, and mayinclude or be configured to be coupled to a distribution component, suchas a dressing. In general, a distribution component may refer to anycomplementary or ancillary component configured to be fluidly coupled toa negative-pressure supply in a fluid path between a negative-pressuresupply and a tissue site. A distribution component is preferablydetachable, and may be disposable, reusable, or recyclable. For example,a dressing 102 may be fluidly coupled to a negative-pressure source 104,as illustrated in FIG. 1. A dressing may include a cover, a tissueinterface, or both in some embodiments. The dressing 102, for example,may include a cover 106 and a tissue interface 108. A regulator or acontroller, such as a controller 110, may also be coupled to thenegative-pressure source 104.

In some embodiments, a dressing interface may facilitate coupling thenegative-pressure source 104 to the dressing 102. For example, such adressing interface may be a SENSAT.R.A.C.™ Pad available from KineticConcepts, Inc. of San Antonio, Tex. The therapy system 100 mayoptionally include a fluid container, such as a container 112, coupledto the dressing 102 and to the negative-pressure source 104.

The therapy system 100 may also include a source of instillationsolution. For example, a solution source 114 may be fluidly coupled tothe dressing 102, as illustrated in the example embodiment of FIG. 1.The solution source 114 may be fluidly coupled to a positive-pressuresource, such as the positive-pressure source 116, in some embodiments,or may be fluidly coupled to the negative-pressure source 104. Aregulator, such as an instillation regulator 118, may also be fluidlycoupled to the solution source 114 and the dressing 102. In someembodiments, the instillation regulator 118 may also be fluidly coupledto the negative-pressure source 104 through the dressing 102, asillustrated in the example of FIG. 1.

Additionally, the therapy system 100 may include sensors to measureoperating parameters and provide feedback signals to the controller 110indicative of the operating parameters. As illustrated in FIG. 1, forexample, the therapy system 100 may include a first sensor 120 and asecond sensor 122 coupled to the controller 110. The first sensor 120may also be coupled or configured to be coupled to a distributioncomponent and to the negative-pressure source 104.

Components may be fluidly coupled to each other to provide a path fortransferring fluids (i.e., liquid and/or gas) between the components.For example, components may be fluidly coupled through a fluidconductor, such as a tube. A “tube,” as used herein, broadly includes atube, pipe, hose, conduit, or other structure with one or more luminaadapted to convey a fluid between two ends. Typically, a tube is anelongated, cylindrical structure with some flexibility, but the geometryand rigidity may vary. In some embodiments, components may also becoupled by virtue of physical proximity, being integral to a singlestructure, or being formed from the same piece of material. Moreover,some fluid conductors may be molded into or otherwise integrallycombined with other components. Coupling may also include mechanical,thermal, electrical, or chemical coupling (such as a chemical bond) insome contexts. For example, a tube may mechanically and fluidly couplethe dressing 102 to the container 112 in some embodiments.

In general, components of the therapy system 100 may be coupled directlyor indirectly. For example, the negative-pressure source 104 may bedirectly coupled to the controller 110, and may be indirectly coupled tothe dressing 102 through the container 112.

A negative-pressure supply, such as the negative-pressure source 104,may be a reservoir of air at a negative pressure, or may be a manual orelectrically-powered device that can reduce the pressure in a sealedvolume, such as a vacuum pump, a suction pump, a wall suction portavailable at many healthcare facilities, or a micro-pump, for example. Anegative-pressure supply may be housed within or used in conjunctionwith other components, such as sensors, processing units, alarmindicators, memory, databases, software, display devices, or userinterfaces that further facilitate therapy. For example, in someembodiments, the negative-pressure source 104 may be combined with thecontroller 110 and other components into a therapy unit. Anegative-pressure supply may also have one or more supply portsconfigured to facilitate coupling and de-coupling the negative-pressuresupply to one or more distribution components.

The tissue interface 108 can be generally adapted to contact a tissuesite. The tissue interface 108 may be partially or fully in contact withthe tissue site. If the tissue site is a wound, for example, the tissueinterface 108 may partially or completely fill the wound, or may beplaced over the wound. The tissue interface 108 may take many forms, andmay have many sizes, shapes, or thicknesses depending on a variety offactors, such as the type of treatment being implemented or the natureand size of a tissue site. For example, the size and shape of the tissueinterface 108 may be adapted to the contours of deep and irregularshaped tissue sites. Moreover, any or all of the surfaces of the tissueinterface 108 may have projections or an uneven, course, or jaggedprofile that can induce strains and stresses on a tissue site, which canpromote granulation at the tissue site.

In some embodiments, the tissue interface 108 may include a manifold. A“manifold” in this context generally includes any substance or structureproviding a plurality of pathways adapted to collect or distribute fluidacross a tissue site under pressure. For example, a manifold may beadapted to receive negative pressure from a source and distributenegative pressure through multiple apertures across a tissue site, whichmay have the effect of collecting fluid from across a tissue site anddrawing the fluid toward the source. In some embodiments, the fluid pathmay be reversed or a secondary fluid path may be provided to facilitatedelivering fluid across a tissue site.

The tissue interface 108 may include either or both of hydrophobic andhydrophilic materials. In an example in which the tissue interface 108may be hydrophilic, the tissue interface 108 may also wick fluid awayfrom a tissue site, while continuing to distribute negative pressure tothe tissue site. The wicking properties of the tissue interface 108 maydraw fluid away from a tissue site by capillary flow or other wickingmechanisms. An example of a hydrophilic foam is a polyvinyl alcohol,open-cell foam such as V.A.C. WHITEFOAM™ Dressing available from KineticConcepts, Inc. of San Antonio, Tex. Other hydrophilic foams may includethose made from polyether. Other foams that may exhibit hydrophiliccharacteristics include hydrophobic foams that have been treated orcoated to provide hydrophilicity.

The tissue interface 108 may further promote granulation at a tissuesite when pressure within the sealed therapeutic environment is reduced.For example, any or all of the surfaces of the tissue interface 108 mayhave an uneven, coarse, or jagged profile that can induce microstrainsand stresses at a tissue site if negative pressure is applied throughthe tissue interface 108.

In some embodiments, the tissue interface 108 may also be constructedfrom one or more bioresorbable materials. Suitable bioresorbablematerials may include, without limitation, a polymeric blend ofpolylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blendmay also include without limitation polycarbonates, polyfumarates, andcapralactones.

In some embodiments, the cover 106 may provide a bacterial barrier andprotection from physical trauma. The cover 106 may also be constructedfrom a material that can reduce evaporative losses and provide a fluidseal between two components or two environments, such as between atherapeutic environment and a local external environment. The cover 106may be, for example, an elastomeric film or membrane that can provide aseal adequate to maintain a negative pressure at a tissue site for agiven negative-pressure source. The cover 106 may have a highmoisture-vapor transmission rate (MVTR) in some applications. Forexample, the MVTR may be at least 250 grams per square meter pertwenty-four hours in some embodiments, measured using an upright cuptechnique according to ASTM E96/E96M Upright Cup Method at 38° C. and10% relative humidity (RH). In some embodiments, an MVTR up to 5,000grams per square meter per twenty-four hours may provide may provideeffective breathability and mechanical properties. In some exampleembodiments, the cover 106 may be a polymer drape, such as apolyurethane film, that is permeable to water vapor but impermeable toliquid. Such drapes typically have a thickness in the range of 25-50microns. For permeable materials, the permeability generally should below enough that a desired negative pressure may be maintained.

An attachment device may be used to attach the cover 106 to anattachment surface, such as undamaged epidermis, a gasket, or anothercover. The attachment device may take many forms. For example, anattachment device may be a medically-acceptable, pressure-sensitiveadhesive that extends about a periphery, a portion, or an entire sealingmember. In some embodiments, for example, some or all of the cover 106may be coated with an acrylic adhesive having a coating weight between25-65 grams per square meter (g.s.m.). Thicker adhesives, orcombinations of adhesives, may be applied in some embodiments to improvethe seal and reduce leaks. Other example embodiments of an attachmentdevice may include a double-sided tape, paste, hydrocolloid, hydrogel,silicone gel, or organogel.

A controller, such as the controller 110, may be a microprocessor orcomputer programmed to operate one or more components of the therapysystem 100, such as the negative-pressure source 104. In someembodiments, for example, the controller 110 may be a microcontroller,which generally comprises an integrated circuit containing a processorcore and a memory programmed to directly or indirectly control one ormore operating parameters of the therapy system 100. Operatingparameters may include the power applied to the negative-pressure source104, the pressure generated by the negative-pressure source 104, or thepressure distributed to the tissue interface 108, for example. Thecontroller 110 is also preferably configured to receive one or moreinput signals, such as a feedback signal, and programmed to modify oneor more operating parameters based on the input signals.

Sensors, such as the first sensor 120 and the second sensor 122, aregenerally known in the art as any apparatus operable to detect ormeasure a physical phenomenon or property, and generally provide asignal indicative of the phenomenon or property that is detected ormeasured. For example, the first sensor 120 and the second sensor 122may be configured to measure one or more operating parameters of thetherapy system 100. In some embodiments, the first sensor 120 may be atransducer configured to measure pressure in a pneumatic pathway andconvert the measurement to a signal indicative of the pressure measured.In some embodiments, for example, the first sensor 120 may be apiezoresistive strain gauge. The second sensor 122 may optionallymeasure operating parameters of the negative-pressure source 104, suchas the voltage or current, in some embodiments. Preferably, the signalsfrom the first sensor 120 and the second sensor 122 are suitable as aninput signal to the controller 110, but some signal conditioning may beappropriate in some embodiments. For example, the signal may need to befiltered or amplified before it can be processed by the controller 110.Typically, the signal is an electrical signal, but may be represented inother forms, such as an optical signal.

The container 112 is representative of a container, canister, pouch, orother storage component, which can be used to manage exudates and otherfluids withdrawn from a tissue site. In many environments, a rigidcontainer may be preferred or required for collecting, storing, anddisposing of fluids. In other environments, fluids may be properlydisposed of without rigid container storage, and a re-usable containercould reduce waste and costs associated with negative-pressure therapy.

The solution source 114 may also be representative of a container,canister, pouch, bag, or other storage component, which can provide asolution for instillation therapy. Compositions of solutions may varyaccording to a prescribed therapy, but examples of solutions that may besuitable for some prescriptions include hypochlorite-based solutions,silver nitrate (0.5%), sulfur-based solutions, biguanides, cationicsolutions, and isotonic solutions.

In operation, the tissue interface 108 may be placed within, over, on,or otherwise proximate to a tissue site. The cover 106 may be placedover the tissue interface 108 and sealed to an attachment surface nearthe tissue site. For example, the cover 106 may be sealed to undamagedepidermis peripheral to a tissue site. Thus, the dressing 102 canprovide a sealed therapeutic environment proximate to a tissue site,substantially isolated from the external environment, and thenegative-pressure source 104 can reduce the pressure in the sealedtherapeutic environment. Negative pressure applied across the tissuesite through the tissue interface 108 in the sealed therapeuticenvironment can induce macrostrain and microstrain in the tissue site,as well as remove exudates and other fluids from the tissue site, whichcan be collected in container 112.

The fluid mechanics of using a negative-pressure source to reducepressure in another component or location, such as within a sealedtherapeutic environment, can be mathematically complex. However, thebasic principles of fluid mechanics applicable to negative-pressuretherapy and instillation are generally well-known to those skilled inthe art, and the process of reducing pressure may be describedillustratively herein as “delivering,” “distributing,” or “generating”negative pressure, for example.

In general, exudates and other fluids flow toward lower pressure along afluid path. Thus, the term “downstream” typically implies something in afluid path relatively closer to a source of negative pressure or furtheraway from a source of positive pressure. Conversely, the term “upstream”implies something relatively further away from a source of negativepressure or closer to a source of positive pressure. Similarly, it maybe convenient to describe certain features in terms of fluid “inlet” or“outlet” in such a frame of reference. This orientation is generallypresumed for purposes of describing various features and componentsherein. However, the fluid path may also be reversed in someapplications (such as by substituting a positive-pressure source for anegative-pressure source) and this descriptive convention should not beconstrued as a limiting convention.

“Negative pressure” generally refers to a pressure less than a localambient pressure, such as the ambient pressure in a local environmentexternal to a sealed therapeutic environment provided by the dressing102. In many cases, the local ambient pressure may also be theatmospheric pressure at which a tissue site is located. Alternatively,the pressure may be less than a hydrostatic pressure associated withtissue at the tissue site. Unless otherwise indicated, values ofpressure stated herein are gauge pressures. Similarly, references toincreases in negative pressure typically refer to a decrease in absolutepressure, while decreases in negative pressure typically refer to anincrease in absolute pressure. While the amount and nature of negativepressure applied to a tissue site may vary according to therapeuticrequirements, the pressure is generally a low vacuum, also commonlyreferred to as a rough vacuum, between −5 mm Hg (−667 Pa) and −500 mm Hg(−66.7 kPa). Common therapeutic ranges are between −75 mm Hg (−9.9 kPa)and −300 mm Hg (−39.9 kPa).

FIG. 2 is an assembly view of an example of the dressing 102 of FIG. 1,illustrating additional details that may be associated with someembodiments in which the tissue interface 108 comprises more than onelayer. In the example of FIG. 2, the tissue interface 108 comprises afirst layer 205, a second layer 210, a third layer 220, and a fourthlayer 225. In some embodiments, the first layer 205 may be disposedadjacent to the second layer 210, and the third layer 220 may bedisposed adjacent to the second layer 210 opposite the first layer 205.Additionally, the fourth layer 225 may be disposed adjacent to the thirdlayer 220 opposite the second layer 210. For example, the first layer205, the second layer 210, the third layer 220, and the fourth layer 225may be stacked so that the first layer 205 is in contact with the secondlayer 210, the second layer 210 is in contact with the first layer 205and the third layer 220, and the third layer 220 is in contact with thesecond layer 210 and the fourth layer 225. One or more of the firstlayer 205, the second layer 210, the third layer 220, and the fourthlayer 225 may also be bonded to an adjacent layer in some embodiments.While the overall dressing 102, including the layers of the tissueinterface 108, is shown in FIG. 2 to have substantially a square shape,the dressing 102 and included layers may be any number of differentshapes, based on the particular anatomical needs of a tissue site. Forexample, the dressing 102 and included layers may have a square,rectangular, oval, circular, hexagonal, or other shape. Additionally,the dressing 102 may further include three-dimensional forms that may bewelded and shaped to address needs of specific types of tissue sites,such as breasts or post-amputation wounds.

The first layer 205 may be a sealing layer comprising or consistingessentially of a soft, tacky material suitable for providing a fluidseal with a tissue site, and may have a substantially flat surface. Forexample, the first layer 205 may comprise, without limitation, asilicone gel, a soft silicone, hydrocolloid, hydrogel, polyurethane gel,polyolefin gel, hydrogenated styrenic copolymer gel, a foamed gel, asoft closed cell foam such as polyurethanes and polyolefins coated withan adhesive, polyurethane, polyolefin, or hydrogenated styreniccopolymers. In some embodiments, the first layer 205 may be in the formof a film, and may have a thickness between about 200 microns (Mm) andabout 1000 microns (Mm). In some embodiments, the first layer 205 mayhave a hardness between about 5 Shore OO and about 80 Shore OO. Further,the first layer 205 may be comprised of hydrophobic or hydrophilicmaterials.

In some embodiments, the first layer 205 may be a hydrophobic-coatedmaterial. For example, the first layer 205 may be formed by coating aspaced material, such as, for example, woven, nonwoven, molded, orextruded mesh with a hydrophobic material. The hydrophobic material forthe coating may be a soft silicone, for example.

The first layer 205 may have a periphery 230 surrounding or around aninterior portion 235, and apertures 240 disposed through the periphery230 and the interior portion 235. The interior portion 235 maycorrespond to a surface area of the second layer 210 in some examples.The first layer 205 may also have corners 245 and edges 250. The corners245 and the edges 250 may be part of the periphery 230. The first layer205 may have an interior border 255 around the interior portion 235,disposed between the interior portion 235 and the periphery 230. Theinterior border 255 may be substantially free of the apertures 240, asillustrated in the example of FIG. 2. In some examples, as illustratedin FIG. 2, the interior portion 235 may be symmetrical and centrallydisposed in the first layer 205.

The apertures 240 may be formed by cutting or by application of local RFor ultrasonic energy, for example, or by other suitable techniques forforming an opening. The apertures 240 may have a uniform distributionpattern, or may be randomly distributed on the first layer 205. Theapertures 240 in the first layer 205 may have many shapes, includingcircles, squares, stars, ovals, polygons, slits, complex curves,rectilinear shapes, triangles, for example, or may have some combinationof such shapes.

Each of the apertures 240 may have uniform or similar geometricproperties. For example, in some embodiments, each of the apertures 240may be circular apertures, having substantially the same diameter. Insome embodiments, the diameter of each of the apertures 240 may bebetween about 1 millimeter to about 50 millimeters. In otherembodiments, the diameter of each of the apertures 240 may be betweenabout 1 millimeter to about 20 millimeters.

In other embodiments, geometric properties of the apertures 240 mayvary. For example, the diameter of the apertures 240 may vary dependingon the position of the apertures 240 in the first layer 205, asillustrated in FIG. 2. In some embodiments, the diameter of theapertures 240 in the periphery 230 of the first layer 205 may be largerthan the diameter of the apertures 240 in the interior portion 235 ofthe first layer 205. For example, in some embodiments, the apertures 240disposed in the periphery 230 may have a diameter between about 9.8millimeters to about 10.2 millimeters. In some embodiments, theapertures 240 disposed in the corners 245 may have a diameter betweenabout 7.75 millimeters to about 8.75 millimeters. In some embodiments,the apertures 240 disposed in the interior portion 235 may have adiameter between about 1.8 millimeters to about 2.2 millimeters.

At least one of the apertures 240 in the periphery 230 of the firstlayer 205 may be positioned at the edges 250 of the periphery 230, andmay have an interior cut open or exposed at the edges 250 that is influid communication in a lateral direction with the edges 250. Thelateral direction may refer to a direction toward the edges 250 and inthe same plane as the first layer 205. As shown in the example of FIG.2, the apertures 240 in the periphery 230 may be positioned proximate toor at the edges 250 and in fluid communication in a lateral directionwith the edges 250. The apertures 240 positioned proximate to or at theedges 250 may be spaced substantially equidistant around the periphery230 as shown in the example of FIG. 2. Alternatively, the spacing of theapertures 240 proximate to or at the edges 250 may be irregular.

The second layer 210 may comprise or consist essentially of a means forcontrolling or managing fluid flow. In some embodiments, the secondlayer 210 may comprise or consist essentially of a liquid-impermeable,elastomeric material. For example, the second layer 210 may comprise orconsist essentially of a non-porous polymer film. The second layer 210may also have a smooth or matte surface texture in some embodiments. Aglossy or shiny finish better or equal to a grade B3 according to theSPI (Society of the Plastics Industry) standards may be particularlyadvantageous for some applications. In some embodiments, variations insurface height may be limited to acceptable tolerances. For example, thesurface of the second layer may have a substantially flat surface, withheight variations limited to 0.2 millimeters over a centimeter.

In some embodiments, the second layer 210 may be hydrophobic. Thehydrophobicity of the second layer 210 may vary, but may have a contactangle with water of at least ninety degrees in some embodiments. In someembodiments, the second layer 210 may have a contact angle with water ofno more than 150 degrees. For example, in some embodiments, the contactangle of the second layer 210 may be in a range of at least 90 degreesto about 120 degrees, or in a range of at least 120 degrees to 150degrees. Water contact angles can be measured using any standardapparatus. Although manual goniometers can be used to visuallyapproximate contact angles, contact angle measuring instruments canoften include an integrated system involving a level stage, liquiddropper such as a syringe, camera, and software designed to calculatecontact angles more accurately and precisely, among other things.Non-limiting examples of such integrated systems may include the FTA125,FTA200, FTA2000, and FTA4000 systems, all commercially available fromFirst Ten Angstroms, Inc., of Portsmouth, Va., and the DTA25, DTA30, andDTA100 systems, all commercially available from Kruss GmbH of Hamburg,Germany. Unless otherwise specified, water contact angles herein aremeasured using deionized and distilled water on a level sample surfacefor a sessile drop added from a height of no more than 5 cm in air at20-25° C. and 20-50% relative humidity. Contact angles reported hereinrepresent averages of 5-9 measured values, discarding both the highestand lowest measured values. The hydrophobicity of the second layer 210may be further enhanced with a hydrophobic coating of other materials,such as silicones and fluorocarbons, either as coated from a liquid orplasma coated.

The second layer 210 may also be suitable for welding to other layers.For example, the second layer 210 may be adapted for welding to otherfilm layers using heat, radio frequency (RF) welding, or other methodsto generate heat such as ultrasonic welding. RF welding may beparticularly suitable for more polar materials, such as polyurethane,polyamides, polyesters and acrylates. Sacrificial polar interfaces maybe used to facilitate RF welding of less polar film materials such aspolyethylene.

The area density of the second layer 210 may vary according to aprescribed therapy or application. In some embodiments, an area densityof less than 40 grams per square meter may be suitable, and an areadensity of about 20-30 grams per square meter may be particularlyadvantageous for some applications.

In some embodiments, for example, the second layer 210 may comprise orconsist essentially of a hydrophobic polymer, such as a polyethylenefilm. The simple and inert structure of polyethylene can provide asurface that interacts little, if any, with biological tissues andfluids, providing a surface that may encourage the free flow of liquidsand low adherence, which can be particularly advantageous for manyapplications. Other suitable polymeric films include polyurethanes,acrylics, polyolefin (such as cyclic olefin copolymers), polyacetates,polyamides, polyesters, copolyesters, PEBAX block copolymers,thermoplastic elastomers, thermoplastic vulcanizates, polyethers,polyvinyl alcohols, polypropylene, polymethylpentene, polycarbonate,styreneics, silicones, fluoropolymers, and acetates. A thickness between20 microns and 100 microns may be suitable for many applications. Filmsmay be clear, colored, or printed. More polar films suitable forlaminating to a polyethylene film include polyamide, copolyesters,ionomers, and acrylics. To aid in the bond between a polyethylene andpolar film, tie layers may be used, such as ethylene vinyl acetate, ormodified polyurethanes. An ethyl methyl acrylate (EMA) film may alsohave suitable hydrophobic and welding properties for someconfigurations.

As illustrated in the example of FIG. 2, the second layer 210 may haveone or more fluid restrictions 260, which can be distributed uniformlyor randomly across the second layer 210. The fluid restrictions 260 maybe bi-directional and pressure-responsive. For example, each of thefluid restrictions 260 generally may comprise or consist essentially ofan elastic passage through the second layer 210 that is normallyunstrained to substantially reduce liquid flow, and can expand or openin response to a pressure gradient. In some embodiments, the fluidrestrictions 260 may comprise or consist essentially of perforations inthe second layer 210. Perforations may be formed by removing materialfrom the second layer 210. For example, perforations may be formed bycutting through the second layer 210, which may also deform the edges ofthe perforations in some embodiments. In the absence of a pressuregradient across the perforations, the passages may be sufficiently smallto form a seal or fluid restriction, which can substantially reduce orprevent liquid flow. Additionally or alternatively, one or more of thefluid restrictions 260 may be an elastomeric valve that is normallyclosed when unstrained to substantially prevent liquid flow, and canopen in response to a pressure gradient. A fenestration in the secondlayer 210 may be a suitable valve for some applications. Fenestrationsmay also be formed by removing material from the second layer 210, butthe amount of material removed and the resulting dimensions of thefenestrations may be up to an order of magnitude less than perforations,and may result in edges that are not deformed. Additionally, in someembodiments, perforations may be formed by mechanical slitting thencontrolled uni- and/or bi-axial stretching of the film material of thesecond layer 210.

For example, some embodiments of the fluid restrictions 260 may compriseor consist essentially of one or more slits, slots, or combinations ofslits and slots in the second layer 210. In some examples, the fluidrestrictions 260 may comprise or consist of linear slots having a lengthless than 4 millimeters and a width less than 1 millimeter. The lengthmay be at least 2 millimeters, and the width may be at least 0.4millimeters in some embodiments. A length of about 3 millimeters and awidth of about 0.5 millimeters may be particularly suitable for manyapplications, and a tolerance of about 0.1 millimeter may also beacceptable. Such dimensions and tolerances may be achieved with a lasercutter, ultrasonics, or other heat means, for example. The linear slitsor slots may be spaced apart by about 2 to 4 millimeters along theirlength and from side-to-side. Slots of such configurations may functionas imperfect valves that substantially reduce liquid flow in a normallyclosed or resting state. For example, such slots may form a flowrestriction without being completely closed or sealed. The slots canexpand or open wider in response to a pressure gradient to allowincreased liquid flow.

The third layer 220 generally comprises or consists essentially of amanifold or a manifold area, which provides a means for collecting ordistributing fluid across the tissue interface 108 under pressure. Forexample, the third layer 220 may be adapted to receive negative pressurefrom a source and distribute negative pressure through multipleapertures across the tissue interface 108, which may have the effect ofcollecting fluid from across a tissue site and drawing the fluid towardthe source. In some embodiments, the fluid path may be reversed or asecondary fluid path may be provided to facilitate delivering fluid,such as from a source of instillation solution, across the tissueinterface 108.

In some embodiments, the third layer 220 may comprise or consistessentially of a film of fluid-impermeable material having bubbles. Insome embodiments, the third layer 220 may comprise a film of transparentmaterial. Polyurethane and polyethylene are examples of suitablefluid-impermeable materials for some applications of the third layer220. In some embodiments, the bubbles may include raised formations,protrusions, spacers, or standoffs. For example, the third layer 220 mayinclude bubbles in the form of blisters 270, which may extend above orbelow a reference plane of the third layer 220. Within each of theblisters 270 may be an empty cavity that may be open to the surroundingenvironment. For example, portions of a film of fluid-impermeablematerial that forms the third layer 220 may be shaped or formed toinclude the blisters 270. In some embodiments, the blisters 270 may bein the form of small vacuum-formed regions of the film of the thirdlayer 220. In some embodiments, each individual blister of the blisters270 may be dome-shaped or hemispherically-shaped. Additionally oralternatively, the blisters 270 may be in the form of raised formationshaving different shapes, such as generally conical, cylindrical, tubularhaving a flattened or hemispherical end, or geodesic. In someembodiments, the third layer 220 may be positioned in the tissueinterface 108 so that the blisters 270 protrude towards or face thesecond layer 210. The pitch and spacing of the blisters 270 may differacross the surface of the third layer 220. For example, the blisters 270may be further spaced apart in a center region of the third layer 220.The third layer 220 may further include apertures 275 to allow fluidtransfer through the film. The blisters 270 may assist with enabling thethird layer 220 to function as the core manifolding layer of the tissueinterface 108. The surface area of the third layer 220, includingblisters 270 and/or apertures 275, may define a manifold area of thethird layer 220 and tissue interface 108.

In some additional embodiments, the third layer 220 may include bubblesin the form of air pockets, which may be either open or closed. Forexample, the bubbles may include closed cells, which may be in the formof sealed air pockets. Additionally or alternatively, the third layer220 may also include ridges, grooves, or other structural featureshaving sufficient rigidity to maintain their shape and form when appliedas part of the tissue interface 108.

The thickness of the third layer 220 may also vary according to needs ofa prescribed therapy. For example, the thickness of the third layer 220may be decreased to relieve stress on other layers and to reduce tensionon peripheral tissue. The thickness of the third layer 220 can alsoaffect the conformability of the third layer 220. In some embodiments,the third layer 220 may comprise a film having a thickness in a range ofabout 20 to 500 micrometers. For example, the third layer 220 maycomprise a film having a thickness of approximately 250 micrometers withblisters 270 having a diameter of between 0.5 mm and 2.0 mm.

The fourth layer 225 may also comprise or consist essentially of amanifold or manifold layer. For example, the fourth layer 225 may beadapted to receive negative pressure from a source and distributenegative pressure through multiple apertures across the tissue interface108, which may have the effect of collecting fluid from across a tissuesite and drawing the fluid toward the source.

In some illustrative embodiments, the fourth layer 225 may comprise aplurality of pathways, which can be interconnected to improvedistribution or collection of fluids. In some embodiments, the fourthlayer 225 may comprise or consist essentially of a porous materialhaving interconnected fluid pathways. For example, cellular foam,open-cell foam, reticulated foam, porous tissue collections, and otherporous material such as gauze or felted mat generally include pores,edges, and/or walls adapted to form interconnected fluid channels.Liquids, gels, and other foams may also include or be cured to includeapertures and fluid pathways. In some embodiments, the fourth layer 225may additionally or alternatively comprise projections that forminterconnected fluid pathways. For example, the fourth layer 225 may bemolded to provide surface projections that define interconnected fluidpathways. Any or all of the surfaces of the fourth layer 225 may have anuneven, coarse, or jagged profile.

In some embodiments, the fourth layer 225 may comprise or consistessentially of a reticulated foam having pore sizes and free volume thatmay vary according to needs of a prescribed therapy. For example, areticulated foam having a free volume of at least 90% may be suitablefor many therapy applications, and a foam having an average pore size ina range of 400-600 microns (40-50 pores per inch) may be particularlysuitable for some types of therapy. The tensile strength of the fourthlayer 225 may also vary according to needs of a prescribed therapy. Forexample, the tensile strength of a foam may be increased forinstillation of topical treatment solutions. The 25% compression loaddeflection of the fourth layer 225 may be at least 0.35 pounds persquare inch, and the 65% compression load deflection may be at least0.43 pounds per square inch. In some embodiments, the tensile strengthof the fourth layer 225 may be at least 10 pounds per square inch. Thefourth layer 225 may have a tear strength of at least 2.5 pounds perinch. In some embodiments, the first layer 225 may be a foam comprisedof polyols such as polyester or polyether, isocyanate such as toluenediisocyanate, and polymerization modifiers such as amines and tincompounds. In one non-limiting example, the fourth layer 225 may be areticulated polyurethane ether foam such as used in GRANUFOAM™ dressingor V.A.C. VERAFLO™ dressing, both available from KCI of San Antonio,Tex.

The thickness of the fourth layer 225 may also vary according to needsof a prescribed therapy. For example, the thickness of the fourth layer225 may be decreased to relieve stress on other layers and to reducetension on peripheral tissue. The thickness of the fourth layer 225 canalso affect the conformability of the fourth layer 225. In someembodiments, a thickness in a range of about 2 millimeters to 10millimeters may be suitable. In some embodiments, the fourth layer 225may be partially or completely opaque, or otherwise be such that thefourth layer 225 may block at least a portion of light passage.

In the example embodiment of FIG. 2, the fourth layer 225 may be sizedand positioned so that the edges of the fourth layer 225 are placedinboard of the edges of the third layer 220. For example, the fourthlayer 225 may have a cross-section parallel to the reference plane ofthe third layer, and the area of the cross-section is less than an areaof a side of the third layer 220. In some embodiments, the fourth layer225 may have a first, or lower, side adapted to be positioned againstthe third layer 220 and a second, or upper, side that may be generallyparallel to the first side of the fourth layer 225. The first side andthe second side of the fourth layer 225 may each have a surface areathat is substantially equal. The surface area of each of the first sideand the second side of the fourth layer 225 may be less than the surfacearea of the side of the third layer 220 positioned adjacent to the firstside of the fourth layer 225.

In some embodiments, the fourth layer 225 may have a first side defininga face 277 having a contact area, which may correspond to a portion ofthe manifold area of the third layer 220. In some embodiments, thecontact area of the face 277 may be less than or smaller than themanifold area of the third layer 220, and also the areas of the otherlayers of the tissue interface 108. For example, the contact area of thefourth layer 225 may be approximately greater than or equal to 30% ofthe manifold area of the third layer 220. A portion of the manifold areaof the third layer 220, or manifold margin 278, may not be covered bythe fourth layer 225. As such, in some embodiments, a portion of anupper surface of the third layer 220 may be exposed to or in contactwith the cover 106, and may also allow a user to view the portion of thethird layer 220 through the cover 106.

In some embodiments, a manifold area of the third layer 220, andlikewise of the tissue interface 108, may be defined by or correspond tothe surface area of an upper or lower side of the third layer 220. Asshown in FIG. 2, the contact area associated with the face 277 of thefourth layer 225 may be positioned against or adjacent to a centralportion of the manifold area of the third layer 220. In suchembodiments, the fourth layer 225 may provide an enhanced manifoldingcapability to the central portion(s) of the manifold area of the thirdlayer 220. This enhanced manifolding to the central portion(s) of themanifold area of the third layer 220 and tissue interface 108 may beadvantageous as the central part of the tissue interface 108 maygenerally be aligned over the tissue site, such as a wound.Additionally, by including a fourth layer 225 that does not extend tothe edges of the manifold area defined by the third layer 220, and thusthe tissue interface 108, interference between the fourth layer 225 andedges of a tissue site, such as a peri-wound area, may be minimized oravoided.

In the example of FIG. 2, the dressing 102 may further include anattachment device, such as an adhesive 280. The adhesive 280 may be, forexample, a medically-acceptable, pressure-sensitive adhesive thatextends about a periphery, a portion, or the entire cover 106. In someembodiments, for example, the adhesive 280 may be an acrylic adhesivehaving a coating weight between 25-65 grams per square meter (g.s.m.).Thicker adhesives, or combinations of adhesives, may be applied in someembodiments to improve the seal and reduce leaks. In some embodiments,such a layer of the adhesive 280 may be continuous or discontinuous.Discontinuities in the adhesive 280 may be provided by apertures orholes (not shown) in the adhesive 280. The apertures or holes in theadhesive 280 may be formed after application of the adhesive 280 or bycoating the adhesive 280 in patterns on a carrier layer such as a sideof the cover 106. Apertures or holes in the adhesive 280 may also besized to enhance the MVTR of the dressing 102 in some exampleembodiments.

As illustrated in the example of FIG. 2, in some embodiments, thedressing 102 may include a release liner 285 to protect the adhesive 280prior to use. The release liner 285 may also provide stiffness to assistwith, for example, deployment of the dressing 102. The release liner 285may be, for example, a casting paper, a film, or polyethylene. Further,in some embodiments, the release liner 285 may be a polyester materialsuch as polyethylene terephthalate (PET) or similar polarsemi-crystalline polymer. The use of a polar semi-crystalline polymerfor the release liner 285 may substantially preclude wrinkling or otherdeformation of the dressing 102. For example, the polar semi-crystallinepolymer may be highly orientated and resistant to softening, swelling,or other deformation that may occur when brought into contact withcomponents of the dressing 102 or when subjected to temperature orenvironmental variations, or sterilization. Further, a release agent maybe disposed on a side of the release liner 285 that is configured tocontact the first layer 205. For example, the release agent may be asilicone coating and may have a release factor suitable to facilitateremoval of the release liner 285 by hand and without damaging ordeforming the dressing 102. In some embodiments, the release agent maybe a fluorocarbon or a fluorosilicone, for example. In otherembodiments, the release liner 285 may be uncoated or otherwise usedwithout a release agent.

FIG. 2 also illustrates one example of a fluid conductor 290 and adressing interface 292. As shown in the example of FIG. 2, the fluidconductor 290 may be a flexible tube, which can be fluidly coupled onone end to the dressing interface 292. The dressing interface 292 may bean elbow connector, as shown in the example of FIG. 2, which can beplaced over an aperture 294 in the cover 106 to provide a fluid pathbetween the fluid conductor 290 and the tissue interface 108. In someembodiments, the fluid conductor 290 may also include a fluid deliveryconduit for use with instillation therapy. Further, in some embodiments,the dressing interface 292 may include multiple fluid conduits, such asa conduit for communicating negative pressure and a fluid deliveryconduit. For example, the dressing interface 292 may be a V.A.C.VERAT.R.A.C.™ Pad.

FIG. 3 is a schematic view of an example of the second layer 210,illustrating additional details that may be associated with someembodiments. As illustrated in the example of FIG. 3, the fluidrestrictions 260 may each consist essentially of one or more linearslots having a length of about 3 millimeters. FIG. 3 additionallyillustrates an example of a uniform distribution pattern of the fluidrestrictions 260. In FIG. 3, the fluid restrictions 260 aresubstantially coextensive with the second layer 210 and are distributedacross the second layer 210 in a grid of parallel rows and columns, inwhich the slots are also mutually parallel to each other. In someembodiments, the rows may be spaced about 3 millimeters on center, andthe fluid restrictions 260 within each of the rows may be spaced about 3millimeters on center as illustrated in the example of FIG. 3. The fluidrestrictions 260 in adjacent rows may be aligned or offset. For example,adjacent rows may be offset, as illustrated in FIG. 3, so that the fluidrestrictions 260 are aligned in alternating rows and separated by about6 millimeters. The spacing of the fluid restrictions 260 may vary insome embodiments to increase the density of the fluid restrictions 260according to therapeutic requirements.

FIG. 4 is a schematic view of an example configuration of the apertures240, illustrating additional details that may be associated with someembodiments of the first layer 205. In some embodiments, the apertures240 illustrated in FIG. 4 may be associated only with the interiorportion 235. In the example of FIG. 4, the apertures 240 are generallycircular and have a diameter of about 2 millimeters. FIG. 4 alsoillustrates an example of a uniform distribution pattern of theapertures 240 in the interior portion 235. In FIG. 4, the apertures 240are distributed across the interior portion 235 in a grid of parallelrows and columns. Within each row and column, the apertures 240 may beequidistant from each other, as illustrated in the example of FIG. 4.FIG. 4 illustrates one example configuration that may be particularlysuitable for many applications, in which the apertures 240 are spacedabout 6 millimeters apart along each row and column, with a 3 millimeteroffset.

FIG. 5 is a schematic view of the example first layer 205 of FIG. 4overlaid on the second layer 210 of FIG. 3, illustrating additionaldetails that may be associated with some example embodiments of thetissue interface 108. For example, as illustrated in FIG. 5, the fluidrestrictions 260 may be aligned, overlapping, in registration with, orotherwise fluidly coupled to the apertures 240 in some embodiments. Insome embodiments, one or more of the fluid restrictions 260 may beregistered with the apertures 240 only in the interior portion 235, oronly partially registered with the apertures 240. The fluid restrictions260 in the example of FIG. 5 are generally configured so that each ofthe fluid restrictions 260 is registered with only one of the apertures240. In other examples, one or more of the fluid restrictions 260 may beregistered with more than one of the apertures 240. For example, any oneor more of the fluid restrictions 260 may be a perforation or afenestration that extends across two or more of the apertures 240.Additionally or alternatively, one or more of the fluid restrictions 260may not be registered with any of the apertures 240.

As illustrated in the example of FIG. 5, the apertures 240 may be sizedto expose a portion of the second layer 210, the fluid restrictions 260,or both through the first layer 205. In some embodiments, each of theapertures 240 may be sized to expose no more than two of the fluidrestrictions 260. In some examples, the length of each of the fluidrestrictions 260 may be substantially equal to or less than the diameterof each of the apertures 240. In some embodiments, the averagedimensions of the fluid restrictions 260 are substantially similar tothe average dimensions of the apertures 240. For example, the apertures240 may be elliptical in some embodiments, and the length of each of thefluid restrictions 260 may be substantially equal to the major axis orthe minor axis. In some embodiments, though, the dimensions of the fluidrestrictions 260 may exceed the dimensions of the apertures 240, and thesize of the apertures 240 may limit the effective size of the fluidrestrictions 260 exposed to the lower surface of the dressing 102.

FIG. 6 is a perspective view of an example of the third layer 220,illustrating additional details that may be associated with someembodiments. As illustrated in the example of FIG. 6, the blisters 270may be generally hemispherical and uniformly distributed in someembodiments.

FIG. 7 is a section view of the third layer 220 of FIG. 6, illustratingadditional details that may be associated with some embodiments. Forexample, the third layer 220 may be formed of a single sheet or film offluid-impermeable material, which may have the blisters 270 andapertures 275 formed thereon. In some embodiments, the third layer 220may be formed from a polyurethane material. The blisters 270 may beformed in the third layer 220 by applying a vacuum to the film offluid-impermeable material of the third layer 220 to create the blisters270. The blisters 270 may have dimensions that depend on the particularapplication of the dressing 102. For example, each of the blisters 270may have a height between approximately 0.5 mm and 3.0 mm and may have adiameter between approximately 1.0 mm and 3.0 mm. In some embodiments,the blisters 270 may measure approximately 1.5 mm in height andapproximately 1.5 mm in diameter. The distance between each of theblisters 270 may be between approximately 0.5 mm and 3.0 mm, and in someembodiments may have a spacing of approximately 2.0 mm.

As shown in FIG. 7, the apertures 275 may be formed in the portions ofthe third layer 220 that are between the blisters 270 and may extendthrough the film of fluid-impermeable material to permit fluids to flowthrough the third layer 220. The number of apertures 275 may varydepending on the type of negative pressure and instillation therapy tobe provided by the therapy system 100. The apertures 275 may havedifferent shapes, such as, for example, circular, elliptical,rectangular, or other irregular shape. Such apertures 275 may have adiameter, major axis, or length between about 0.5 mm and 2.0 mm. In someexample embodiments, the apertures 275 may be formed by cutting orperforating, punching, or cutting using a laser or heat thefluid-impermeable material of the third layer 220.

In some embodiments of the dressing 102, one or more components of thedressing 102 may additionally be treated with an antimicrobial agent.For example, the first layer 205, the second layer 210, the third layer220, and/or the fourth layer 225 may be coated with an antimicrobialagent. In some embodiments, the second layer 210 may comprise a polymercoated or mixed with an antimicrobial agent. In further embodiments, thethird layer 220 may comprise films coated or mixed with an antimicrobialagent. In other examples, the cover 106, the fluid conductor 290, thedressing interface 292, or other portion of the dressing 102 mayadditionally or alternatively be treated with one or more antimicrobialagents. Suitable antimicrobial agents may include, for example, metallicsilver, PHMB, iodine or its complexes and mixes such as povidone iodine,copper metal compounds, chlorhexidine, or some combination of thesematerials.

Individual components of the dressing 102 may be bonded or otherwisesecured to one another with a solvent or non-solvent adhesive, or withthermal welding, for example, without adversely affecting fluidmanagement. Further, the second layer 210 or the third layer 220 may becoupled to the border 255 of the first layer 205 in any suitable manner,such as with a weld or an adhesive, for example.

The cover 106, the first layer 205, the second layer 210, the thirdlayer 220, the fourth layer 225, or various combinations may beassembled before application or in situ. For example, the cover 106 maybe laminated to the fourth layer 225 and/or the third layer 220, and thesecond layer 210 may be laminated to the third layer 220 opposite thecover 106 in some embodiments. The first layer 205 may also be coupledto the second layer 210 opposite the third layer 220 in someembodiments. In some embodiments, one or more layers of the tissueinterface 108 may be coextensive. For example, the third layer 220 maybe coextensive with the second layer 210, as illustrated in theembodiment of FIG. 2. In some embodiments, the dressing 102 may beprovided as a single, composite dressing. For example, the first layer205 may be coupled to the cover 106 to enclose the second layer 210, thethird layer 220, and the fourth layer 225, wherein the first layer 205is configured to face a tissue site.

In additional embodiments, the dressing 102 may be provided withdifferent combinations of the individual layers and components. Forexample, the tissue interface 108, such as the tissue interface 108shown in FIG. 2, may be provided as a standalone product for applying toa tissue site. In some further embodiments, individual layers of thetissue interface 108 and the dressing 102 may be omitted. For example,in some embodiments, the tissue interface 108 may be provided with thesecond layer 210, the third layer 220, and fourth layer 225 positionedbetween the second layer 210 and the third layer 220. In suchembodiments, the third layer 220 may be configured to include a fluidport for mating with a dressing interface, such as dressing interface292.

In use, the release liner 285 (if included) may be removed to expose thefirst layer 205, which may be placed within, over, on, or otherwiseproximate to a tissue site, particularly a surface tissue site andadjacent epidermis. The first layer 205, second layer 210, and thirdlayer 220 may be interposed between the fourth layer 225 and the tissuesite, which can substantially reduce or eliminate adverse interactionwith the fourth layer 225. For example, the first layer 205 may beplaced over a surface wound (including edges of the wound) and undamagedepidermis to prevent direct contact with the fourth layer 225. Treatmentof a surface wound or placement of the dressing 102 on a surface woundincludes placing the dressing 102 immediately adjacent to the surface ofthe body or extending over at least a portion of the surface of thebody. Treatment of a surface wound does not include placing the dressing102 wholly within the body or wholly under the surface of the body, suchas placing a dressing within an abdominal cavity. In some applications,the interior portion 235 of the first layer 205 may be positionedadjacent to, proximate to, or covering a tissue site. In someapplications, at least some portion of the second layer 210, the fluidrestrictions 260, or both may be exposed to a tissue site through thefirst layer 205. The periphery 230 of the first layer 205 may bepositioned adjacent to or proximate to tissue around or surrounding thetissue site. The first layer 205 may be sufficiently tacky to hold thedressing 102 in position, while also allowing the dressing 102 to beremoved or re-positioned without trauma to the tissue site.

Removing the release liner 285 can also expose the adhesive 280, and thecover 106 may be attached to an attachment surface. For example, thecover 106 may be attached to epidermis peripheral to a tissue site,around the fourth layer 225, the third layer 220, and the second layer210. The adhesive 280 may be in fluid communication with an attachmentsurface through the apertures 240 in at least the periphery 230 of thefirst layer 205 in some embodiments. The adhesive 280 may also be influid communication with the edges 250 through the apertures 240 exposedat the edges 250.

Once the dressing 102 is in the desired position, the adhesive 280 maybe pressed through the apertures 240 to bond the dressing 102 to theattachment surface. The apertures 240 at the edges 250 may permit theadhesive 280 to flow around the edges 250 for enhancing the adhesion ofthe edges 250 to an attachment surface.

In some embodiments, apertures or holes in the first layer 205 may besized to control the amount of the adhesive 280 in fluid communicationwith the apertures 240. For a given geometry of the corners 245, therelative sizes of the apertures 240 may be configured to maximize thesurface area of the adhesive 280 exposed and in fluid communicationthrough the apertures 240 at the corners 245. For example, as shown inFIG. 2, the edges 250 may intersect at substantially a right angle, orabout 90 degrees, to define the corners 245. In some embodiments, thecorners 245 may have a radius of about 10 millimeters. Further, in someembodiments, three of the apertures 240 having a diameter between about7.75 millimeters to about 8.75 millimeters may be positioned in atriangular configuration at the corners 245 to maximize the exposedsurface area for the adhesive 280. In other embodiments, the size andnumber of the apertures 240 in the corners 245 may be adjusted asnecessary, depending on the chosen geometry of the corners 245, tomaximize the exposed surface area of the adhesive 280. Further, theapertures 240 at the corners 245 may be fully housed within the firstlayer 205, substantially precluding fluid communication in a lateraldirection exterior to the corners 245. The apertures 240 at the corners245 being fully housed within the first layer 205 may substantiallypreclude fluid communication of the adhesive 280 exterior to the corners245, and may provide improved handling of the dressing 102 duringdeployment at a tissue site. Further, the exterior of the corners 245being substantially free of the adhesive 280 may increase theflexibility of the corners 245 to enhance comfort.

In some embodiments, the bond strength of the adhesive 280 may vary indifferent locations of the dressing 102. For example, the adhesive 280may have a lower bond strength in locations adjacent to the first layer205 where the apertures 240 are relatively larger, and may have a higherbond strength where the apertures 240 are smaller. Adhesive 280 withlower bond strength in combination with larger apertures 240 may providea bond comparable to adhesive 280 with higher bond strength in locationshaving smaller apertures 240.

The geometry and dimensions of the tissue interface 108, the cover 106,or both may vary to suit a particular application or anatomy. Forexample, the geometry or dimensions of the tissue interface 108 and thecover 106 may be adapted to provide an effective and reliable sealagainst challenging anatomical surfaces, such as an elbow or heel, atand around a tissue site. Additionally or alternatively, the dimensionsmay be modified to increase the surface area for the first layer 205 toenhance the movement and proliferation of epithelial cells at a tissuesite and reduce the likelihood of granulation tissue in-growth.

Thus, the dressing 102 in the example of FIG. 2 can provide a sealedtherapeutic environment proximate to a tissue site, substantiallyisolated from the external environment, and the negative-pressure source104 can reduce the pressure in the sealed therapeutic environment. Thefirst layer 205 may provide an effective and reliable seal againstchallenging anatomical surfaces, such as an elbow or heel, at and arounda tissue site. Further, the dressing 102 may permit re-application orre-positioning, to correct air leaks caused by creases and otherdiscontinuities in the dressing 102, for example. The ability to rectifyleaks may increase the efficacy of the therapy and reduce powerconsumption in some embodiments.

If not already configured, the dressing interface 292 may be disposedover the aperture 294 and attached to the cover 106. The fluid conductor290 may be fluidly coupled to the dressing interface 292 and to thenegative-pressure source 104.

Negative pressure applied through the tissue interface 108 can create anegative pressure differential across the fluid restrictions 260 in thesecond layer 210, which can open or expand the fluid restrictions 260from their resting state. For example, in some embodiments in which thefluid restrictions 260 may comprise substantially closed fenestrationsthrough the second layer 210, a pressure gradient across thefenestrations can strain the adjacent material of the second layer 210and increase the dimensions of the fenestrations to allow liquidmovement through them, similar to the operation of a duckbill valve.Opening the fluid restrictions 260 can allow exudate and other liquidmovement through the fluid restrictions 260, through the apertures 275of the third layer 220, and into the fourth layer 225 and the container112. Changes in pressure can also cause the fourth layer 225 to expandand contract, and the third layer 220 as well as the interior border 255of the first layer 205 may protect the epidermis from irritation causedby movement of the fourth layer 225. The third layer 220, the secondlayer 210, and the first layer 205 can also substantially reduce orprevent exposure of tissue to the fourth layer 225, which can inhibitgrowth of tissue into the fourth layer 225.

In some embodiments, the fourth layer 225 may be hydrophobic to minimizeretention or storage of liquid in the dressing 102. In otherembodiments, the fourth layer 225 may be hydrophilic. In an example inwhich the fourth layer 225 may be hydrophilic, the fourth layer 225 mayalso wick fluid away from a tissue site, while continuing to distributenegative pressure to the tissue site. The wicking properties of thefourth layer 225 may draw fluid away from a tissue site by capillaryflow or other wicking mechanisms, for example. An example of ahydrophilic fourth layer 225 is a polyvinyl alcohol, open-cell foam suchas V.A.C. WHITEFOAM™ Dressing available from Kinetic Concepts, Inc. ofSan Antonio, Tex. Other hydrophilic foams may include those made frompolyether. Other foams that may exhibit hydrophilic characteristicsinclude hydrophobic foams that have been treated or coated to providehydrophilicity.

If the negative-pressure source 104 is removed or turned-off, thepressure differential across the fluid restrictions 260 can dissipate,allowing the fluid restrictions 260 to move to their resting state andprevent or reduce the rate at which exudate or other liquid can returnto the tissue site through the second layer 210.

In some applications, a filler may also be disposed between a tissuesite and the first layer 205. For example, if the tissue site is asurface wound, a wound filler may be applied interior to the periwound,and the first layer 205 may be disposed over the periwound and the woundfiller. In some embodiments, the filler may be a manifold, such as anopen-cell foam. The filler may comprise or consist essentially of thesame material as the fourth layer 225 in some embodiments.

Additionally or alternatively, instillation solution or other fluid maybe distributed to the dressing 102, which can increase the pressure inthe tissue interface 108. The increased pressure in the tissue interface108 can create a positive pressure differential across the fluidrestrictions 260 in the second layer 210, which can open or expand thefluid restrictions 260 from their resting state to allow theinstillation solution or other fluid to be distributed to the tissuesite.

FIG. 8 is a schematic diagram of another example of the dressing 102.While many of the components of the dressing 102 of FIG. 8 may be thesame as or similar to those of the dressing 102 of FIG. 2, differenceswith respect to the individual layers of the dressings may beidentified. For example, the dressing 102 of FIG. 8 may include a tissueinterface 108 having a fourth layer 225 that is of a different shapeand/or configuration than the fourth layer 225 of FIG. 2. As shown inFIG. 8, in some embodiments, the fourth layer 225 may be in the shape ofa star or other similar shape having a central region 810 and one ormore appendages, such as radial legs 812 or regions, extending from thecentral region 810. The fourth layer 225 may have an approximatethickness of between 4 mm and 10 mm, and in some embodimentsapproximately 6 mm. The face 277 of the fourth layer 225 may define acontact area that is shaped by, defined by, or includes the centralregion 810 and/or one or more appendages, such as the radial legs 812.The fourth layer 225 may be placed above or against a manifold area ofthe third layer 220, and may provide enhanced manifolding to theportions of the manifold area of the third layer 220 placed against thecontact area defined by the central region 810 and radial legs 812 ofthe fourth layer 225. The size of the contact area provided by thecentral region 810 and the radial legs 812 of the fourth layer 225 maybe based on the dimensions of the other layers, such as the third layer220, in the tissue interface 108. In some embodiments, the contact areaprovided by the fourth layer 225 may be approximately greater than orequal to 30% of the manifold area of the third layer 220.

As discussed with respect to FIG. 2, the perimeter of the third layer220 may define the borders of a manifold area of the tissue interface108. In some embodiments, the radial legs 812 of the fourth layer 225may substantially extend to the edges of the third layer 220 and to theborders of the manifold area. For example, the radial legs 812 of thefourth layer 225 may extend approximately 90% of the length and/or widthof the manifold area of the third layer 220. Stated another way, in someembodiments, a margin of about 10% of length and/or width dimensions ofthe manifold area of the third layer 220 may be included beyond theextended area of the radial legs 812. Portions of the third layer 220within the manifold area may not be placed against or covered by aportion of the contact area of the fourth layer 225, and thus portionsof the upper side of the third layer 220 within the manifold area may beexposed to the cover 106 of the dressing 102. The portions of the thirdlayer 220 not covered by the central region 810 or radial legs 812 ofthe fourth layer 225 may remain visible to a user looking upon thedressing 102. Furthermore, since in some embodiments of the tissueinterface 108, the third layer 220, second layer 210, and first layer205 may each comprise one or more transparent material(s), a portion orportions of the tissue site may remain visible to a user throughout thewear duration of the dressing 102. The shape and configuration of thefourth layer 225 of FIG. 8 may allow for enhanced visibility of a tissuesite through the manifold area of the third layer 220 between the radiallegs 812. The fourth layer 225 of FIG. 8 may also ensure that thedressing 102 continues to provide improved manifolding capability to allportions of the manifold area that may be aligned with a tissue site,including outer edges of the manifold area which may correspond tounderlying peri-wound areas of the tissue site.

FIG. 9 is a schematic diagram illustrating a dressing 102 according toadditional example embodiments. The tissue interface 108 of the dressing102 may include a fourth layer 225 in the shape of an ‘X’ or othersimilar shape having a central region 910 and appendages, such as radiallegs 912, extending from the central region 910. The fourth layer 225may be placed above or against the manifold area of the third layer 220,and may provide enhanced manifolding to the portions of the manifoldarea of the third layer 220 placed against the contact area defined bythe central region 810 and radial legs 812 of the fourth layer 225. Theperimeter of the third layer 220 of the tissue interface 108 may definethe borders of a manifold area of the tissue interface 108.

In comparison to the fourth layer 225 of FIG. 8, the fourth layer 225 ofFIG. 9 may include larger, but may have fewer appendages, such as radiallegs 912, extending from the central region 910. In some embodiments,the radial legs 912 may be shorter in length than the radial legs 812 ofFIG. 8, and thus the radial legs 912 may not extend as far toward theouter edges of the manifold area of the third layer 220. However, insome embodiments, the radial legs 912 may each have a greater width thanthe radial legs 812 of FIG. 8. For example, each of the radial legs 912may have a width of approximately 25-50% greater than the width of eachof the radial legs 812 of FIG. 8. Additionally, the fourth layer 225 ofFIG. 9 may have a greater thickness than the fourth layer 225 of FIG. 8.For example, the thickness of the fourth layer 225 of FIG. 9 may beapproximately between 4 mm and 10 mm. The fourth layer 225 of FIG. 9 maythus also provide enhanced manifolding to portions of the manifold areaof the third layer 220 that are placed against or covered by a portionof the contact area of the ‘X’-shaped fourth layer 225. The portions ofthe third layer 220 that are not covered or placed against a portion ofthe fourth layer 225, or those portions of the third layer 220 outsideof the contact area of the fourth layer 225, may be exposed to the cover106 of the dressing 102, and thus may remain visible to a user. Theconfiguration of the fourth layer 225 having an ‘X’ shape may providefor improved visibility through the layers of the tissue interface 108that correspond to portions of the manifold area of the third layer 220not associated with the fourth layer 225, which may include a manifoldmargin 278 around the perimeter of the manifold area as well as someinterior portions of the manifold area between the radial legs 912. Thefourth layer 225 of FIG. 9 may provide a high level of manifolding toboth the inner and outer areas of the manifold area of the third layer220. The ‘X’-shaped fourth layer 225 of FIG. 9 may allow for both goodvisibility through the manifold margin 278 of the third layer 220 aswell as good flexibility of the manifold margin 278 of the third layer220. The manifold margin 278 may align with the portion of the tissueinterface 108 that is for placing or applying against a peri-wound areaof a tissue site. Thus, both enhanced visibility through and goodflexibility of the tissue interface 108 may be particularly beneficialduring application of the dressing 102, when a user may be attempting toalign the edges of the manifold area with a portion of the peri-woundarea.

FIG. 10 is a schematic diagram illustrating another example of thedressing 102. While the components of the dressing 102 of FIG. 10 may bethe same as or similar to those of the dressing 102 of FIG. 2, thearrangement and/or order of the layers of the dressing 102 of FIG. 10may be different. For example, the individual layers of the tissueinterface 108 of FIG. 10 may be arranged or stacked in a different orderthan the layers of the tissue interface 108 of FIG. 2. Morespecifically, in some embodiments, rather than the fourth layer 225being placed above the third layer 220, or between the third layer 220and the cover 106, the fourth layer 225 of FIG. 10 may be placed belowor under the third layer 220. Thus, in the example embodiment of FIG.10, the tissue interface 108 may include a fourth layer 225 positionedbetween the second layer 210 and the third layer 220. As shown in FIG.10, the third layer 220 may be oriented so that the blisters 270 areprotruding downwards and in contact with the fourth layer 225. In otherembodiments, the orientation of the third layer 220 may also bereversed. As shown in FIG. 10, the fourth layer 225 may have a squareshape similar to the fourth layer 225 of FIG. 2, however, the fourthlayer 225 of FIG. 10 may also have different shapes or configurations,such as the star-shaped configuration or X-shaped configuration of FIG.8 and FIG. 9, respectively. The fourth layer 225 of FIG. 10 may enhancemanifolding through a manifold area of the third layer 220 associatedwith a contact area defined by a face 277 of the fourth layer 225. Thefourth layer 225 may also provide good visibility of the tissue sitethrough the layers of the tissue interface 108 and dressing 102, as thecontact area of the fourth layer 225 may be smaller than the manifoldarea of the third layer 220, the second layer 210, and the first layer205, all of which may be at least partially transparent.

In some additional or alternative embodiments, the fourth layer 225 maycomprise a foam material that allows for an additional degree ofvisibility through the tissue interface 108. For example, the fourthlayer 225 may be formed from a coarse, stiff reticulated foam, such as a2 pores per inch (ppi) to 3 ppi reticulated foam having a pore size ofbetween about 2 mm to 10 mm. In some embodiments, the foam of the fourthlayer 225 may be a Z3SA material, commercially available from FXI ofPennsylvania, USA. Furthermore, the foam of the fourth layer 225 may bemade from a non-pigmented polymer, such as a polyurethane, which mayprovide an additional degree of translucency. In some additionalembodiments, the fourth layer 225 may include a portion of coarser foam,such as a 2 ppi to 10 ppi foam, laminated to a portion of perforated 45ppi foam, such as the foam more typically included in other disclosedembodiments of the fourth layer 225 of the tissue interface 108. In someinstances, the fourth layer 225 may have a reduced material content,which may allow for better delivery of possible instilled treatmentfluids to an underlying wound and periwound area, as well as develop ahigher fluid shear or washing effect of the tissue interfaces.

In some further embodiments, other features may be suitable for thefourth layer 225. For example, rather than a foam material, the fourthlayer 225 may be in the form of a non-woven that is perforated withholes having a diameter of between about 5 mm and 10 mm. In furtherinstances, the foam of the fourth layer 225 may be replaced bythree-dimensional spacer textiles, where hole formations have been woveninto the upper and lower surfaces of the textiles. In some furtherembodiments, the fourth layer 225 may include a felted perforated foam.In yet further embodiments, the fourth layer 225 may be formed from afoam having large perforations, and the perforations may have variousshapes, such as circular, lenticular, polygonal, as well as othershapes. In some cases, larger perforations of the foam may allow thefourth layer 225 to better handle thick or highly-viscous woundexudates.

In yet further embodiments, the fourth layer 225 may be formed from anembossed perforated film, such as a film having bubbles similar to thoseof the third layer 220, in place of a foam material. The embossedperforated film may provide an improved degree of transparency. Inadditional embodiments, the fourth layer 225 may comprise one or morelayers of a molded mesh or apertured film having a pore size rangingfrom about 2 mm to 10 mm in diameter, such as materials commerciallyavailable from DelStar Technologies, Inc., of Middletown, Del., USA. Insome instances, reducing the amount of foam material, or usingsubstitute materials instead of foam for the fourth layer 225, mayprovide the tissue interface 108 with increased flexibility. Theincreased flexibility may allow the tissue interface 108 to betterconform and seal to traditionally-challenging wound locations, such asjoints, feet, hands, amputation sites, and sacral anatomies.

Additional features may also be included in some embodiments of thetissue interface 108. For example, to further aid manifolding in areasof the tissue interface which may be between radial arms of the fourthlayer 225, such as the radial legs 812 or radial legs 912 of theembodiments of FIGS. 8 and 9, respectively, portions of the second layer210 may be embossed. In some instances, the second layer 210 may beembossed on the surface facing away from the tissue site, so as toretain a smooth surface of the second layer 210 that faces the wound orperiwound areas of the tissue site. Examples of suitable embossed filmfor use as the second layer 210 may be available from Charter Nex ofWisconsin, USA. Additionally, some embodiments of the fourth layer 225may have radial arms formed from reticulated foam, woven or non-wovenmaterial, or bubble material with web-like interconnections.

Methods of treating a surface wound to promote healing and tissuegranulation may include applying the dressing 102 to a surface wound andsealing the dressing 102 to epidermis adjacent to the surface wound. Forexample, the first layer 205 may be placed over the surface wound,covering at least a portion of the edge of the surface wound and aperiwound adjacent to the surface wound. The cover 106 may also beattached to epidermis around the first layer 205. The dressing 102 maybe fluidly coupled to a negative-pressure source, such as thenegative-pressure source 104. Negative pressure from thenegative-pressure source 104 may be applied to the dressing 102, openingthe fluid restrictions 260. The fluid restrictions 260 can be closed byblocking, stopping, or reducing the negative pressure. The third layer220, the second layer 210, and the first layer 205 can substantiallyprevent exposure of tissue in the surface wound to the fourth layer 225,inhibiting growth of tissue into the fourth layer 225. The dressing 102can also substantially prevent maceration of the periwound.

In additional embodiments, methods of treating a surface wound mayinclude applying the dressing 102 to a surface wound and sealing thedressing 102 to epidermis adjacent to the surface wound. The dressing102 may include a lower layer comprising a first film of at leastpartially transparent, liquid-impermeable material having a plurality offluid restrictions to allow the passage of fluid from a wound sitethrough the lower layer. The dressing 102 may further include an upperlayer positioned above the lower layer, where the upper layer comprisesa second film of a transparent material and further comprising a fluidport for mating with a source of negative pressure. Additionally, thedressing 102 may include an intermediate layer between the lower layerand the upper layer. The intermediate layer may include a foam, and thearea of the foam may be less than the area of the lower layer in orderto allow visualization of the surface wound underneath the upper andlower layers. The dressing 102 may further include a third film coupledto the lower layer opposite the upper layer, where the third filmcomprises a hydrophobic material having a plurality of apertures. Insome embodiments, the hydrophobic material may be silicone.

The systems, apparatuses, and methods described herein may providesignificant advantages over prior dressings. For example, some dressingsfor negative-pressure therapy can require significant time and skill tobe properly sized and applied to achieve a good fit and seal. Incontrast, the dressing 102 can be simple to apply, reducing the time toapply and remove. In some embodiments, for example, the dressing 102 maybe a fully-integrated negative-pressure therapy dressing that can beapplied to a tissue site (including on the periwound) in one step,without being cut to size, while still providing or improving manybenefits of other negative-pressure therapy dressings that requiresizing. Such benefits may include good manifolding, beneficialgranulation, protection of the peripheral tissue from maceration, and alow-trauma and high-seal bond. The dressing 102 may also conform to andoccupy a significant space at a tissue site. These characteristics maybe particularly advantageous for surface wounds having moderate depthand medium-to-high levels of exudate, and thus may offer significantbenefits to tissue sites beyond those including only shallow, surfacewounds.

The dressing 102 can also promote granulation while reducing theopportunity for in-growth of granulation tissue into the layers of thetissue interface 108. For example, by containing porous material withinother layers comprising materials such as silicone and/or polyethylene,high levels of granulation to the tissue site may be achieved whileavoiding significant amounts of tissue in-growth to the dressing 102.Furthermore, macro-strains may be provided to the edges of a tissuesite, such as wound edges, while preventing maceration of thesurrounding peri-wound area. As a result, reduced trauma to the tissuesite upon dressing removal may achieved, while also allowing for longerdressing wear time. Additionally, by including a layer that does notspan across the entire manifold area of the other layers of the dressing102, the dressing 102 may offer the combined benefits of a transparentpressure manifold to offer visibility of the tissue site while alsoincluding the superior pressure manifolding capabilities of a foammaterial optimized for rapid removal of high volumes of fluid. Thedressing 102 may promote granulation with reduced possibility of tissuein-growth that can be worn for extended wear times, for example up toseven days. Additionally, caregivers, may be able to visualize thetissue site through portions of the manifold area of the dressing duringan extended wear time, without disrupting the dressing.

Another associated advantage of the disclosed dressings may be that theneed for a user to size or cut a portion of foam, such as foamassociated with the fourth layer 225, to ensure that the foam ispositioned in-board of wound edges to avoid irritation and/or macerationto peri-wound tissue, may be eliminated. The need for applying a largerprotective border of other layers of a dressing, such as the dressing102, to the peri-wound area, sometimes known as applying a “window-pane”to the peri-wound area, due to fear of incorrectly sizing the foamgranulating layers of the dressing 102, may also be eliminated. Forexample, the need to apply strips of a protective material around theborders of the tissue site by users who are concerned about a foam orother manifold being in contact with and macerating the peri-wound area,may be reduced or eliminated. Thus, the disclosed dressings may providea wound filler and/or cover that allows for the management of fluids,manifolds negative pressure, but does not macerate the wound edges orrequire sizing. Since the opaque foam manifold components of thedisclosed dressings may not extend over the entire manifolding area ofthe other dressing layer(s), users may be able to visualize the woundthrough the at least partially transparent other layers corresponding tothe manifolding area of the dressing, which may make alignment of themanifolding area of the dressing over the wound easier. In someembodiments, the disclosed dressings may also provide compression aroundthe wound, thus reducing oedema. Some embodiments of the dressing 102may remain on the tissue site for at least 5 days, and some embodimentsmay remain for at least 7 days. Antimicrobial agents in the dressing 102may extend the usable life of the dressing 102 by reducing oreliminating infection risks that may be associated with extended use,particularly use with infected or highly exuding wounds. Additionally,some embodiments of the dressing 102 may be used with existing systemsfor providing negative-pressure and/or fluid instillation therapy totissue sites.

While shown in a few illustrative embodiments, a person having ordinaryskill in the art will recognize that the systems, apparatuses, andmethods described herein are susceptible to various changes andmodifications. Moreover, descriptions of various alternatives usingterms such as “or” do not require mutual exclusivity unless clearlyrequired by the context, and the indefinite articles “a” or “an” do notlimit the subject to a single instance unless clearly required by thecontext. Components may be also be combined or eliminated in variousconfigurations for purposes of sale, manufacture, assembly, or use. Forexample, in some configurations the dressing 102, the container 112, orboth may be eliminated or separated from other components formanufacture or sale. In other example configurations, the controller 110may also be manufactured, configured, assembled, or sold independentlyof other components.

The appended claims set forth novel and inventive aspects of the subjectmatter described above, but the claims may also encompass additionalsubject matter not specifically recited in detail. For example, certainfeatures, elements, or aspects may be omitted from the claims if notnecessary to distinguish the novel and inventive features from what isalready known to a person having ordinary skill in the art. Features,elements, and aspects described herein may also be combined or replacedby alternative features serving the same, equivalent, or similar purposewithout departing from the scope of the invention defined by theappended claims.

1. A dressing for treating a tissue site with negative pressure, thedressing comprising: a first film comprising a non-porous material and aplurality of fluid restrictions; a first manifold layer adjacent to thefirst film, the first manifold layer comprising a second film of atransparent material having a manifold area comprising blisters andapertures, wherein the apertures are configured to allow fluid transferthrough the second film; and a second manifold layer adjacent to thefirst manifold layer, the second manifold layer comprising foam having acontact area that is less than the manifold area.
 2. The dressing ofclaim 1, wherein: the manifold area has a first shape; the contact areahas a second shape; and the first shape is analogous to the secondshape.
 3. The dressing of claim 1, wherein: the manifold area has afirst shape; the contact area has a second shape; the first shape isanalogous to the second shape; and the manifold area comprises a borderarea around the contact area.
 4. The dressing of claim 1, wherein thecontact area comprises at least three appendages adjacent to themanifold area.
 5. The dressing of claim 1, wherein the contact areacomprises at least three radial appendages adjacent to the manifoldarea.
 6. The dressing of claim 1, wherein the contact area comprises: acentral region; and at least three appendages coupled to the centralregion.
 7. The dressing of claim 1, wherein the contact area comprises:a central region; and at least three appendages coupled to the centralregion and extending to an edge of the manifold area.
 8. The dressing ofclaim 1, wherein the transparent material comprises polyurethane orpolyethylene.
 9. The dressing of claim 1, wherein the foam is ahydrophobic polymer foam.
 10. (canceled)
 11. (canceled)
 12. The dressingof claim 1, wherein the foam is reticulated open-celled foam. 13.(canceled)
 14. The dressing of claim 1, wherein the foam is reticulatedpolyurethane ether foam.
 15. (canceled)
 16. The dressing claim 1,wherein the foam is porous and has an average pore size in a range of400-600 microns.
 17. (canceled)
 18. The dressing of claim 1, wherein thefoam has a thickness in a range of 2 millimeters to 7 millimeters. 19.(canceled)
 20. The dressing of claim 1, wherein the blisters are spacedabout 2 millimeters apart.
 21. The dressing of claim 1, wherein theblisters have a height of about 0.5 millimeters to about 2 millimeters.22. The dressing of claim 1, wherein the blisters have a width of about1 millimeter to about 3 millimeters.
 23. (canceled)
 24. The dressing ofclaim 1, wherein the second manifold layer is substantially opaque. 25.The dressing of claim 1, wherein: the blisters are spaced about 2millimeters apart; the blisters have a height of about 1.5 millimeters;and the blisters have a diameter of about 1.5 millimeters.
 26. Adressing for treating a tissue site with negative pressure, the dressingcomprising: a film layer of non-porous material; a plurality of fluidrestrictions through the film layer; a first manifold layer adjacent tothe film layer, the first manifold layer comprising a transparentmaterial; apertures configured to allow fluid transfer through the firstmanifold layer; and a second manifold layer adjacent to the firstmanifold layer, the second manifold layer comprising foam; wherein atleast a portion of the transparent material is exposed beyond one ormore perimeter edges of the foam.
 27. The dressing of claim 26, wherein:the first manifold layer has a periphery defining a manifold area; thefoam is a cylinder having a face defining a surface area; and thesurface area of the face of the foam is less than the manifold area. 28.The dressing of claim 26, wherein the foam comprises radial legs. 29.The dressing of claim 26, wherein the foam comprises at least threeradial legs.
 30. The dressing of claim 26, wherein the foam comprises atleast four radial legs.
 31. (canceled)
 32. The dressing of claim 26,wherein the foam has a star shape.
 33. The dressing of claim 26, whereinthe portion of the transparent material is exposed around the foam whenviewed from a top of the dressing.
 34. A dressing for treating a tissuesite with negative pressure, the dressing comprising: a fluid controllayer; a first manifold layer adjacent to the fluid control layer, thefirst manifold layer configured to allow visibility of at least part ofthe tissue site through the first manifold layer; and a second manifoldlayer coupled to the first manifold layer; wherein the first manifoldlayer is visible around the second manifold layer.
 35. A dressing fortreating a tissue site with negative pressure, the dressing comprising:a lower layer comprising a first film of at least partially transparent,liquid-impermeable material having a first side and a second side, andfurther comprising a plurality of fluid restrictions to allow thepassage of fluid from the tissue site through the lower layer; an upperlayer positioned above the lower layer, the upper layer comprising: asecond film of a transparent material, the upper layer furthercomprising a fluid port for mating with a source of negative pressure;and an intermediate layer between the lower layer and the upper layer,the intermediate layer comprising foam, wherein a surface area of a faceof the foam is less than a surface area of the second side of the firstfilm of the lower layer to allow visualization of the tissue siteunderneath the upper and lower layers.
 36. The dressing of claim 35,wherein the second film comprises protrusions.
 37. The dressing of claim35, wherein second film comprises spacers, wherein each spacer has aheight of about 0.5 millimeters to about 2 millimeters.
 38. The dressingof claim 35, wherein the surface area of the face of the foam is lessthan 50% of the surface area of the second side of the first film of thelower layer.
 39. The dressing of claim 35, wherein the upper layerextends beyond a perimeter of the lower layer.
 40. The dressing of claim35, wherein the upper layer further comprises an adhesive applied to afirst surface of the upper layer.
 41. The dressing of claim 35, furthercomprising a third film coupled to the lower layer opposite the upperlayer, the third film comprising a hydrophobic material having aplurality of apertures.
 42. The dressing of claim 41, wherein thehydrophobic material is a gel.
 43. The dressing of claim 41, wherein thehydrophobic material comprises silicone.
 44. A dressing for treating atissue site with negative pressure, the dressing comprising: a firstfilm comprising a non-porous material; a second film adjacent to thefirst film, the second film comprising: a transparent material having afirst side and a second side, wherein each of the first side and thesecond side have a surface area, and apertures configured to allow fluidtransfer through the transparent material; and a manifold layer adjacentto the second side of the second film, the manifold layer comprisingfoam having a face defining a face area that is less than the surfacearea of the second side of the second film.
 45. A dressing for treatinga tissue site with negative pressure, the dressing comprising: a firstfilm comprising a non-porous material and a plurality of fluidrestrictions; a second film adjacent to the first film, the second filmcomprising: a transparent material having raised formations, andapertures configured to allow fluid transfer through the transparentmaterial; and a manifold layer adjacent to the second film, the manifoldlayer comprising foam; wherein the foam has a cross-section parallel tothe second film, and the area of the cross-section is less than an areaof a side of the second film.
 46. A dressing for treating a tissue sitewith negative pressure, the dressing comprising: a first layercomprising a first non-porous material and having a first side and asecond side; a second layer adjacent to the second side of the firstlayer, the second layer comprising a transparent material having a firstside and a second side, and further comprising apertures configured toallow fluid transfer through the second layer; and a third layer havinga first side and a second side parallel to the first side, wherein thefirst side of the third layer is positioned adjacent to the second sideof the second layer, and the first side and the second side of the thirdlayer each has a surface area that is less than a surface area of thesecond side of the second layer; wherein the third layer comprises afoam.
 47. A method for treating a tissue site, comprising: positioning adressing on the tissue site, the dressing comprising: a first filmcomprising a non-porous material and a plurality of fluid restrictions,a first manifold layer adjacent to the first film, the first manifoldlayer comprising a second film of a transparent material having amanifold area comprising blisters and apertures, and a second manifoldlayer adjacent to the first manifold layer, the second manifold layercomprising foam having a contact area that is less than the manifoldarea; inspecting the position of the dressing against areas of thetissue site by visualizing the areas of the tissue site through portionsof the first film and first manifold layer; and adjusting the positionof the dressing so that the manifold area of the dressing substantiallycorresponds to areas of the tissue site within borders of the tissuesite.
 48. The method of claim 47, further comprising applying negativepressure to the dressing.
 49. The method of claim 47, wherein: themanifold area has a first shape; the contact area has a second shape;and the first shape is analogous to the second shape.
 50. The method ofclaim 47, wherein the manifold area comprises a border area around thecontact area.
 51. The method of claim 47, wherein the contact areacomprises at least three appendages adjacent to the manifold area. 52.The method of claim 47, wherein the transparent material comprisespolyurethane or polyethylene.
 53. The method of claim 47, wherein thefoam has a thickness in a range of 4 millimeters to 10 millimeters. 54.The method of claim 47, wherein the blisters have a height of about 0.5millimeters to about 2 millimeters.
 55. (canceled)